Senior Director, Global CMC Regulatory Strategy

Kardigan, Inc.; Princeton (NJ); Hybrid; USD 241,000 - 300,000; Full time

Job summary

Kardigan is seeking a Senior Director, CMC Regulatory to lead CMC regulatory strategies and drive global submissions for late-stage assets. The role reports to Head of CMC Regulatory and collaborates with cross-functional teams across development and manufacturing in Princeton, NJ (onsite four days per week).

The successful candidate will manage health authority interactions, ensure compliance with FDA, EMA and ICH guidelines, and shape regulatory strategies to support marketing approval while

Qualifications

• Bachelor’s degree in a scientific discipline required; chemistry advanced degree preferred.
• At least 10 years in CMC regulatory affairs or related roles.
• Experience with IND/IMPD and NDA/MAA submissions and health authority interactions.
• Strong knowledge of FDA, EMA, ICH guidelines.
• Ability to lead cross-functional teams and manage multiple projects.

Responsibilities

• Lead development and execution of CMC regulatory strategies across programs.
• Ensure on-time, global CMC submissions for development-stage programs.
• Manage regulatory interactions with health authorities and respond to questions.
• Provide regulatory expertise on CMC strategies to cross-functional teams.
• Monitor regulatory trends and changes to regulations; adapt strategies.
• Evaluate manufacturing and quality changes for impact on submissions.
• Develop and implement department SOPs and manage staff as needed.

Skills

Regulatory affairs

CMC knowledge

Cross-functional collaboration

Regulatory submissions

Communication skills

Education

Bachelor's degree in sciences

Advanced degree in Chemistry

Job description

Kardigan is seeking a Senior Director, CMC Regulatory to lead CMC regulatory strategies and drive global submissions for late-stage assets. The role reports to Head of CMC Regulatory and collaborates with cross-functional teams across development and manufacturing in Princeton, NJ (onsite four days per week).

The successful candidate will manage health authority interactions, ensure compliance with FDA, EMA and ICH guidelines, and shape regulatory strategies to support marketing approval while